- Genmab (NJ)
- …the clinical trial portfolio. This role serves as a Subject Matter Expert (SME) in protocol quality, central and local lab data, and protocol deviations and is a ... of third-party external data (eg, labs, eCOA, biomarkers, imaging).Serve as SME in protocol quality, lab data integrity (central and local), and management of … more
- Aequor (Athens, GA)
- …near Athens Provides animal husbandry and health care in accordance with experimental protocol and Animal Welfare Act/Regulations, NIH Guide for the Care and Use of ... this individual conducts scientific procedures in accordance with study protocols , completes and maintains appropriate documentation associated with all job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and reviews (clinical trial protocols and ... diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher ... level. Reviews and oversee completion of clinical trial protocols . Provides medical and/or scientific direction to Clinical Operations. Represents Clinical… more
- Merck & Co. (Rahway, NJ)
- …deliverables per company and regulatory requirements, leveraging study protocols , established templates, libraries, glossaries, and risk language.Acquires and ... high-quality documents that reflect the principles of health literacy.Collaborates with protocol authors and clinical teams to ensure understanding of required… more
- Merck & Co. (Rahway, NJ)
- …consent deliverables per company and regulatory requirements, leveraging study protocols , established templates, libraries, glossaries, and risk language.Applies an ... high-quality documents that reflect the principles of health literacyCollaborates with protocol authors and clinical teams to ensure comprehensive understanding of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Lead Engineer, Validation (Supervisor) Essential Functions Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final ... equipment, processes and instrumentation as needed Write and review protocols , summary reports and other documentation associated with validations Coordinate… more
- Merck & Co. (Rahway, NJ)
- …the setting of objectives, budget, resources, timelines, and the study protocol /related documentation.Provide overall leadership and support to the study team. ... staff within the specified study timeline.Train the study team on the Study Protocol Ensure the timely selection and ordering of study materials. Ensure compliance… more
- Tris Pharma (Monmouth Junction, NJ)
- …clarity of scientific content, the incumbent contributes to development of research protocols and supporting regulatory submissions. She/he plays a crucial role in ... but not limited to: New Drug Applications (NDAs), study protocols , clinical study reports, investigator brochures, regulatory submissions, etc.Ensures accuracy,… more
- Formation Bio (New York, NY)
- …writing, review, and finalization of clinical development documents such as protocol synopses and protocols , Investigator's brochures (IBs), clinical summaries ... and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high ... and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position works under some supervision to solve complex study problems.Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis ... Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Associate Manager within Clinical Operations, in adherence to the protocol , Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), ... and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.Compile… more
- Beckman Coulter Diagnostics (Miami, FL)
- …IMV, COV) to perform proactive document/data review to identify discrepancies and protocol deviations, overseeing corrective actions to drive compliance with study ... protocol (s). Effectively escalate and collaborate with site personnel and internal team members to propose solutions to sustain good compliance.Support development of… more
- Merck & Co. (Rahway, NJ)
- …as appropriate, in site management and selection decisions. Provide input into protocol - design, feasibility, and resource assessments as appropriate. Support the ... development and management of Investigator relationships in conjunction with the - R&D Therapy Areas, Global Clinical Development and when appropriate, Human Health - colleagues. Contribute to the program life-cycle management through effective study… more
- Merck & Co. (North Wales, PA)
- …to patient enrollment and retention efforts to achieve study milestones. Protocol lead responsibilities in collaboration with Global Clinical Trial ... OperationsAddresses questions from investigators and provides information regarding participation in Company-sponsored clinical studiesScientific Congress SupportEngages in scientific congresses and medical meetings, facilitates scientific and data exchange… more
- Merck & Co. (Durham, NC)
- …support across the areas. Deliver validation-related projects, including planning, protocol generation, execution, and summary of results in technical reports. ... Manage timely implementation and closeout of validation deliverables to meet production and supply timelines. Stay abreast of current trends in industry and innovate to drive continuous improvement. Represent the site in internal collaborations through our… more
- Merck & Co. (Rahway, NJ)
- …medicine.The Senior Principal Scientist/Senior Director is responsible for protocol development and medical/scientific oversight of clinical research studies ... involving new or marketed drugs in the Vaccines Clinical Research group. He/she will be responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to V clinical trials, preparation of… more
- Merck & Co. (Rahway, NJ)
- …Medical Research, Mentorship, Parasitology, Patient Care, Professional Networking, Protocol Development, Regulatory Compliance {+ 4 more}-Preferred Skills:Job ... Posting End Date:06/28/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R352481 more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and key medical education initiatives.Develops prospective ... contingency plans for management of assigned safety risks across projects; Clearly defines priorities and high-level execution plans across and effective alignment within (eg with translational research, clinical operations, clinical development, medical… more
Related Job Searches:
Adas Networking Protocols Software,
Ports Protocols Service Management,
Software Wireless Protocols Engineer,
Sr Video Protocols Software,
Virtual Protocols Lead Emulation